Sascha Krüger

Magnetic Resonance–Guided Cardiac Interventions Using Magnetic Resonance–Compatible DevicesClinical Perspective

Background— Percutaneous cardiac interventions are currently performed under x-ray guidance. Magnetic resonance imaging (MRI) has been used to guide intravascular interventions in the past, but mainly in animals. Translation of MR-guided interventions into humans has been limited by the lack of MR-compatible and safe equipment, such as MR guide wires with mechanical characteristics similar to standard guide wires. The aim of the present study was to evaluate the safety and efficacy of a newly developed MR-safe and compatible passive guide wire in aiding MR-guided cardiac interventions in a swine model and describe the 2 first-in-man solely MR-guided interventions. Methods and Results— In the preclinical trial, the new MR-compatible wire aided the performance of 20 interventions in 5 swine. These consisted of balloon dilation of nondiseased pulmonary and aortic valves, aortic arch, and branch pulmonary arteries. After ethics and regulatory authority approval, the 2 first-in-man MR-guided interventions were performed in a child and an adult, both with elements of valvar pulmonary stenosis. Catheter manipulations were monitored with real-time MRI sequence with interactive modification of imaging plane and slice position. Temporal resolution was 11 to 12 frames/s. Catheterization procedure times were 110 and 80 minutes, respectively. Both patients had successful relief of the valvar stenosis and no procedural complications. Conclusions— The described preclinical study and case reports are encouraging that with the availability of the new MR-compatible and safe guide wire, certain percutaneous cardiac interventions will become feasible to perform solely under MR guidance in the future. A clinical trial is underway in our institution.Background—Percutaneous cardiac interventions are currently performed under x-ray guidance. Magnetic resonance imaging (MRI) has been used to guide intravascular interventions in the past, but mainly in animals. Translation of MR-guided interventions into humans has been limited by the lack of MR-compatible and safe equipment, such as MR guide wires with mechanical characteristics similar to standard guide wires. The aim of the present study was to evaluate the safety and efficacy of a newly developed MR-safe and compatible passive guide wire in aiding MR-guided cardiac interventions in a swine model and describe the 2 first-in-man solely MR-guided interventions. Methods and Results—In the preclinical trial, the new MR-compatible wire aided the performance of 20 interventions in 5 swine. These consisted of balloon dilation of nondiseased pulmonary and aortic valves, aortic arch, and branch pulmonary arteries. After ethics and regulatory authority approval, the 2 first-in-man MR-guided interventions were performed in a child and an adult, both with elements of valvar pulmonary stenosis. Catheter manipulations were monitored with real-time MRI sequence with interactive modification of imaging plane and slice position. Temporal resolution was 11 to 12 frames/s. Catheterization procedure times were 110 and 80 minutes, respectively. Both patients had successful relief of the valvar stenosis and no procedural complications. Conclusions—The described preclinical study and case reports are encouraging that with the availability of the new MR-compatible and safe guide wire, certain percutaneous cardiac interventions will become feasible to perform solely under MR guidance in the future. A clinical trial is underway in our institution.

Preclinical evaluation of a novel fiber compound MR guidewire in vivo.

Purpose:Interventional magnetic resonance imaging requires dedicated and MR-compatible devices. The guidewire is a key item for intravascular interventions. Mechanical stability, good visibility during real-time imaging, and RF safety are essential. A novel fiber-compound MR guidewire (GW) was evaluated in different MR-guided interventional scenarios. Materials and Methods:The GW (diameter 0.032”) consists of a fiber-compound produced using a micropultrusion technique doped with iron particles and a 10-cm Nitinol tip. Several iron splints are additionally attached at regular distances to visualize GW-movement. A protective polymer jacket with hydrophilic coating covers the core material. As approved by the government committee on animal investigations, the GW was evaluated in 5 pigs. Under complete MR-guidance, catheterization of the carotid and renal arteries, segmental arteries of the kidneys, the contralateral inguinal artery, and the left ventricle was performed using real-time gradient echo sequences in a 1.5 Tesla scanner. Different interventional applications including balloon dilatation, stent deployment, and embolization of small vessels were investigated. The time to probe the vessels under magnetic resonance imaging guidance and visibility of the GW are assessed. Handling and visibility under fluoroscopy were compared with a standard Nitinol guidewire as a benchmark. Results:On real-time magnetic resonance imaging, the iron-induced artifacts enabled a distinct visualization of the GW shaft and of its markings with a mean size of 2.6 mm and 5.4 mm, respectively. This facilitated fast navigation to the target vessels (averages: renal arteries 16 seconds, carotid artery 5 seconds, and contralateral inguinal artery 42 seconds.) with an exact depiction of the respective vessel. All interventional procedures were performed successfully. No GW-related side effects as kinking or breakage of the wire or GW induced blood-clotting were observed. All interventionalists assessed handling of the GW to be nearly equal in terms of stiffness, flexibility, and guidance compared with a standard Nitinol guidewire. X-ray visibility was less distinct but still diagnostically good. Conclusion:With the aid of the GW, different fully real-time MR-guided endovascular interventions become feasible.

Magnetic resonance imaging of the cardiac venous system and magnetic resonance-guided intubation of the coronary sinus in swine: a feasibility study.

Objectives:To visualize the coronary sinus using magnetic resonance (MR), and to demonstrate the feasibility of MR-guided intubation of the cardiac venous system (CVS) in swine. Materials and Methods:A total of 6 pigs were investigated. All experiments were performed using an interventional 1.5-Tesla MRI system. The CVS was visualized using an inversion-recovery navigator-gated whole-heart steady-state free-precession sequence after administration of gadobenate dimeglumine contrast agent. The coronary sinus was then intubated under MR-guidance with a passive MR-compatible guidewire modified by incorporation of iron oxide markers for improved visualization and a nonbraided Cobra-catheter. MR-guided interventions were monitored using a steady-state free-precession real-time imaging sequence. Time needed was measured for MR-guided intubation of the CVS and compared with the time needed for fluoroscopy guided intubation of the CVS. Results:Visualization and intubation of the coronary sinus and its site branches was feasible in all cases. Time spent for MR-guided intubation of the CVS was comparable to time spent for fluoroscopy-guided intubation (8.2 ± 2 minutes vs. 8.3 ± 1.3 minutes; P = 0.85). Conclusions:MR-visualization and MR-guided intubation of the coronary sinus and its side branches is feasible. The feasibility of MR-guided intubation of the CVS might have relevance for procedures like cardiac resynchronization therapy and percutaneous transcatheter mitral annuloplasty, requiring improved 3-dimensional knowledge about cardiac vein anatomy in the near future.

Rapid Right Ventricular Pacing with MR-compatible Pacemaker Lead for MR-guided Aortic Balloon Valvuloplasty in Swine

PURPOSE To assess the feasibility and effectiveness of rapid right ventricular pacing with a magnetic resonance (MR)-compatible pacemaker lead during MR-guided aortic valvuloplasty. MATERIALS AND METHODS This study was approved by the institutional animal research committee. Seven pigs were investigated. All experiments were performed with an interventional 1.5-T MR system. Interventions were monitored with a steady-state free precession real-time imaging sequence. An MR-compatible pacemaker lead was placed in the right ventricular apex with MR guidance before valvuloplasty. After positioning the balloon in valve position, valvuloplasty was performed with rapid right ventricular rapid pacing at a heart rate of 180 beats per minute to minimize cardiac output. RESULTS Positioning of the pacemaker lead with MR guidance was feasible in all swine (sensing, 6 mV +/- 1; threshold, 1 V +/- 0.5). The lead could be seen on steady-state free precession images without inducing any artifacts. Rapid right ventricular pacing was feasible in all swine, and balloon stability at the time of inflation was achieved with no balloon movement. Aortic valvuloplasty was successfully accomplished in all experiments. CONCLUSION Rapid right ventricular pacing with an MR-compatible pacemaker lead is feasible and effective.

Comprehensive MRI-guided intracardiac electrophysiological interventions in swine using a combination of active tracking and passive real-time catheter imaging

Methods A 3D data set containing heart and thoracic vessels was acquired in 8 swine (37-42 kg) using a 1.5T MR-scanner and a breath hold 3D-whole-heart-sequence. An advanced MR-EP-platform (iSuite, Philips Research Hamburg) created auto-registered 3D-models of all cardiac chambers. Two MRI conditional steerable diagnostic and ablation catheters (Vision, Imricor Medical Systems) were inserted via femoral sheaths. Active catheter tracking was performed using the magnetic field to localize inductive coils assembled on the EPcatheter. The coils were shown as a virtual catheter icon displayed in real-time in the auto-segmented/auto-registered 3D-model, in the pre-acquired MRI planes, and during further scanning. The positions of the catheter tip were confirmed by fully balanced steady-state-freeprecession (SSFP) sequence with a frame rate of 8 per second. Initially the CS was intubated. After transseptal access the catheter was brought into all PVs. Subsequently bi-atrial SR activation map was acquired. Ablation procedures were performed alternately in the PVs, the cavotricuspidal isthmus and the posterior wall of the right atrium. For visualization of the myocardial edema and necrosis a T2-weighted turbo-spin-echo and a 2D-T1-weighted phase sensitive inversion recovery sequence was used respectively. After RVOT access the AV-node was ablated, the pig sacrificed and the explanted hearts inspected for ablation lesions.

MR-guided renal denervation: first experience in pigs

Background Renal nerve ablation under fluoroscopy has emerged as a promising therapy in patients non-responding to oral anti-hypertensive medications. However, a considerable drawback of this technique is the lack of exact and immediate therapy control. CMR has the advantage of simultaneously combining functional imaging, anatomic and intraprocedural guidance in one examination without radiation and ionidied contrast agents.

Magnetic Resonance–Guided Cardiac Interventions Using Magnetic Resonance–Compatible DevicesClinical Perspective: A Preclinical Study and First-in-Man Congenital Interventions

Background— Percutaneous cardiac interventions are currently performed under x-ray guidance. Magnetic resonance imaging (MRI) has been used to guide intravascular interventions in the past, but mainly in animals. Translation of MR-guided interventions into humans has been limited by the lack of MR-compatible and safe equipment, such as MR guide wires with mechanical characteristics similar to standard guide wires. The aim of the present study was to evaluate the safety and efficacy of a newly developed MR-safe and compatible passive guide wire in aiding MR-guided cardiac interventions in a swine model and describe the 2 first-in-man solely MR-guided interventions. Methods and Results— In the preclinical trial, the new MR-compatible wire aided the performance of 20 interventions in 5 swine. These consisted of balloon dilation of nondiseased pulmonary and aortic valves, aortic arch, and branch pulmonary arteries. After ethics and regulatory authority approval, the 2 first-in-man MR-guided interventions were performed in a child and an adult, both with elements of valvar pulmonary stenosis. Catheter manipulations were monitored with real-time MRI sequence with interactive modification of imaging plane and slice position. Temporal resolution was 11 to 12 frames/s. Catheterization procedure times were 110 and 80 minutes, respectively. Both patients had successful relief of the valvar stenosis and no procedural complications. Conclusions— The described preclinical study and case reports are encouraging that with the availability of the new MR-compatible and safe guide wire, certain percutaneous cardiac interventions will become feasible to perform solely under MR guidance in the future. A clinical trial is underway in our institution.Background—Percutaneous cardiac interventions are currently performed under x-ray guidance. Magnetic resonance imaging (MRI) has been used to guide intravascular interventions in the past, but mainly in animals. Translation of MR-guided interventions into humans has been limited by the lack of MR-compatible and safe equipment, such as MR guide wires with mechanical characteristics similar to standard guide wires. The aim of the present study was to evaluate the safety and efficacy of a newly developed MR-safe and compatible passive guide wire in aiding MR-guided cardiac interventions in a swine model and describe the 2 first-in-man solely MR-guided interventions. Methods and Results—In the preclinical trial, the new MR-compatible wire aided the performance of 20 interventions in 5 swine. These consisted of balloon dilation of nondiseased pulmonary and aortic valves, aortic arch, and branch pulmonary arteries. After ethics and regulatory authority approval, the 2 first-in-man MR-guided interventions were performed in a child and an adult, both with elements of valvar pulmonary stenosis. Catheter manipulations were monitored with real-time MRI sequence with interactive modification of imaging plane and slice position. Temporal resolution was 11 to 12 frames/s. Catheterization procedure times were 110 and 80 minutes, respectively. Both patients had successful relief of the valvar stenosis and no procedural complications. Conclusions—The described preclinical study and case reports are encouraging that with the availability of the new MR-compatible and safe guide wire, certain percutaneous cardiac interventions will become feasible to perform solely under MR guidance in the future. A clinical trial is underway in our institution.

New Materials for Magnetic Resonance Imaging (MRI) – Fiber-Reinforced Guide Wires and Catheters for Minimal Invasive Interventions

The use of Magnetic Resonance Imaging (MRI) in minimal invasive interventions has created new opportunities for the diagnosis and treatment of illnesses while reducing the exposure of doctors and patients to potentially harmful radiation. But it also requires the development of new MR-capable surgical instruments such as guide wires and catheters.

Ultrasonic diaphragm tracking for cardiac interventional navigation on 3D motion compensated static roadmaps

In this paper, a novel approach to cardiac interventional navigation on 3D motion-compensated static roadmaps is presented. Current coronary interventions, e.g. percutaneous transluminal coronary angioplasties, are performed using 2D X-ray fluoroscopy. This comes along with well-known drawbacks like radiation exposure, use of contrast agent, and limited visualization, e.g. overlap and foreshortening, due to projection imaging. In the presented approach, the interventional device, i.e. the catheter, is tracked using an electromagnetic tracking system (MTS). Therefore, the catheters position is mapped into a static 3D image of the volume of interest (VOI) by means of an affine registration. In order to compensate for respiratory motion of the catheter with respect to the static image, a parameterized affine motion model is used which is driven by a respiratory sensor signal. This signal is derived from ultrasonic diaphragm tracking. The motion compensation for the heartbeat is done using ECG-gating. The methods are validated using a heart- and diaphragm-phantom. The mean displacement of the catheter due to the simulated organ motion decreases from approximately 9 mm to 1.3 mm. This result indicates that the proposed method is able to reconstruct the catheter position within the VOI accurately and that it can help to overcome drawbacks of current interventional procedures.